MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S3,22.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Catalog Number	962346
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent revision due to pain.Patient's femoral component was found to be slightly loose so it was removed and replaced with another femoral component of the same size.The loosening interface was at the bone to cement.Cement manufacturer is unknown.The poly insert was also replaced.No further information is available.Doi: unknown.Dor: (b)(6) 2023.Affected side: left knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed, as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown.Therefore, a device history review could not be performed.  if the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: TC3 RP TIBIAL INSERT S3,22.5
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18074892
• Report Number: 1818910-2023-22623
• Device Sequence Number: 7684921
• Product Code: NJL
• UDI-Device Identifier: 10603295242277
• UDI-Public: 10603295242277
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 962346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); PFC*SIGMA TC3 FEM LEFT SZ3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female